Pancreaticobiilary Diseases
Conditions
Brief summary
This is a single-center randomized controlled trial. Eligible subjects meeting inclusion/exclusion criteria will be randomized 1:1 to EUS+ERCP group or ERCP group. Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. A comparative analysis was conducted to assess the impact of same-session EUS on ERCP strategy modification between two groups, utilizing a structured questionnaire.Secondarily, the safety and efficacy of same-session EUS will be comprehensively evaluated by comparing complication rates, technical success rate and hospitalization costs, length of stay, and radiation exposure between groups.
Interventions
PROCEDUREEUS+ERCP
EUS were performed during the same session with ERCP under continuous sedation/anesthesia
PROCEDUREERCP
Only ERCP was performed in the control group
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years; 2. Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists ); 3. No prior history of ERCP; 4. No pancreaticobiliary EUS examinations within the preceding 3 months.
Exclusion criteria
1. Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance; 2. Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ; 3. Patients with anatomical alterations or surgical history affecting EUS feasibility; 4. Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures; 5. Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP); 6. Pregnancy or lactation; 7. Patients with severe coagulopathy; 8. Declined informed consent; 9. Severe psychiatric disorder/non-cooperation precluding safe procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ERCP strategy modification rate | From enrollment to 6 months after the end of treatment | Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure outcomes | From enrollment to 6 months after the end of treatment | Technical success rate (defined as successful completion of intended therapeutic intervention) ERCP procedure time (from duodenoscope insertion to withdrawal) Difficult cannulation rate (requiring advanced techniques or \>5 attempts) |
| Incidence of complications | From enrollment to 6 months after the end of treatment | — |
| Radiation-related situation | From enrollment to 6 months after the end of treatment | Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²) |
| Healthcare utilization measures | From enrollment to 6 months after the end of treatment | Hospital length of stay (days) Total hospitalization costs |
Countries
China
Contacts
Primary ContactZhen Li, MD,PhD
Outcome results
None listed